Ilya Pharma AB

Complicated, hard-to-heal wounds are a growing medical problem and there are currently only two drugs approved with proven efficacy. In a new study on humans, researchers show that treatment with a specific type of modified lactic acid bacteria works well and has a positive effect on the healing of wounds. Complicated, hard-to-heal wounds are a growing medical problem and there are currently only two drugs approved with proven efficacy. In a new study on humans, researchers at Uppsala University show that treatment with a specific type of modified lactic acid bacteria works well and has a positive effect on the healing of wounds. In several controlled preclinical models, the research team behind the new study has previously demonstrated accelerated wound healing after topical treatment (treatment on the skin) using lactic acid bacteria, or Limosilactobacillus reuteri, genetically modified to produce the chemokine CXCL12 (ILP100-Topical). The researchers can now show data from the first clinical study on humans, in which the main objective was to establish safety and tolerability. Other objectives were to see clinical and biological effects on wound healing using traditionally accepted methods, as well as more exploratory and traceable measurements. 36 healthy volunteers were included in the study with a total of 240 induced wounds studied. The study's design and methodology are described in more detail below. The results show that treatment using ILP100-Topical was safe and well tolerated among all individuals and doses, and neither ILP100 nor CXCL12 could be detected in locations beyond the wounds. A significantly higher proportion of healed wounds (p=0.020) was seen on day 32 using multi-dose ILP100-Topical compared to saline and placebo (76% (73/96) and 59% (57/96) healed wounds respectively) when the results from the multi-dose-treated wounds were pooled. In addition, the time to first recorded healing was reduced by an average of 6 days, and by 10 days at the highest dose. The mechanism of action of ILP100-Topical was also confirmed when the treatment resulted in increased CXCL12-positive cells in the wounds, as well as increased blood flow around the wounds during the healing phase. "Our study shows that bacteria modified to produce and deliver human protein for local effects can be used as drugs to accelerate the healing of wounds. This is the first time this has been shown in controlled human studies, and it can be expected that the effect is greater in patients with diseases that negatively affect wound healing," explains Mia Phillipson, Professor at the Department of Medical Cell Biology at Uppsala University. The favourable safety pro the beneficial effects on wound healing observed here support further clinical development of ILP100-Topical for the treatment of complex and hard-to-heal wounds in patients, which is already under way. Many immune-active proteins are inherently unstable and degrade quickly, so supplying them from lactic acid bacteria to the exact site of action is one way to develop them as drugs. "The potential is really endless when you consider how important a role proteins play in various processes in the body, and how many diseases we currently do not have good enough treatments for. We have already produced another drug candidate to cure and reduce inflammation in the gut of cancer patients -- ILP100-Oral -- and in the future we will start a research project with another chemokine for the treatment of lung diseases," concludes Phillipson. Methods: SITU-SAFE is an adaptive, randomised, double-blind, placebo-controlled, phase 1 study (EudraCT 2019-000680-24) consisting of a single ascending dose (SAD) part for each participant and a multiple ascending dose (MAD) part for each participant. Both parts of the study each consisted of three dose cohorts. A total of 240 wounds were induced on the upper arms of 36 healthy volunteers, including 4 wounds (2/arm) in 12 participants in the SAD arm, and 8 wounds (4/arm) in 24 participants in the MAD arm. The wounds were randomised for treatment using a placebo, saline or ILP100-Topical. The study was conducted at the Phase 1 unit at Uppsala University Hospital in Uppsala, Sweden, and sponsored by Ilya Pharma.

Biopharma and life sciences companies from around the globe provide updates on their businesses and pipelines. Germany-based BioMed X Institute expanded its collaboration with Merck KGaA, Darmstadt, Germany to include a total of eight research programs in the field of DNA damage response and RNA splicing. The expanded program will explore the role of extrachromosomal circular DNA (ecDNA) in cancer, which complements current oncology programs being studies by BioMed X. Extrachromosomal circular DNA has been found to be abundant in multiple human cancer cells, however its frequency can vary among different cancer types. Elevated levels of ecDNA have been considered to be correlated with poor clinical outcome in human cancers, BioMed X said. The partnership with Merck KGaA aims to generate comprehensive data of extrachromosomal DNA in human cancer tissues and investigate how (onco)genes in ecDNA could contribute to tumorigenesis, disease progression, tumor heterogeneity, metastasis, and treatment resistance. Additionally, the program aims to develop novel therapeutic strategies based on oncogenic alterations in ecDNA. Christian Tidona, Founder and Managing Director of the BioMed X Institute said the program will further cancer research and strengthen the company’s expertise in deep cancer biology. Elsewhere around the globe: Mimetas – Netherlands-based MIMETAS struck a partnership with Roche to develop human disease models to characterize novel compounds in inflammatory bowel disease (IBD) and hepatitis B virus infections (HBV). MIMETAS will be responsible for developing tissue-based disease models and assays in the OrganoPlate, its proprietary organ-on-chip platform. Roche will gain access to technology, disease models, and scientific results. Financial terms of the collaboration were not disclosed. Y-Biologics – South Korea’s -Biologics and the French pharmaceutical group Pierre Fabre have entered into a license agreement for antibodies generated through the phage display human antibody Ymax-ABL library owned by Y-Biologics. These antibodies included in the deal have been functionally validated by the Pierre Fabre R&D teams for their specific properties on a pivotal immuno-oncology. Pierre Fabre intends to select a new therapeutic candidate in immuno-oncology for further developments. Novasep – France’s Novasep signed a manufacturing services agreement with U.S. based Exelixis for the cGMP clinical production of XB002, a next-generation tissue factor-targeting antibody-drug conjugate (ADC) for oncology applications. XB002 is a novel ADC composed of a human monoclonal antibody against tissue factor that is conjugated to a cytotoxic agent and leverages proprietary linker-payload technology. Ilya Pharma – Sweden’s Ilya Pharma will present its ILP100 accelerated wound healing therapy at the US Military Health System Research Symposium next month. Ilya will present data explaining how this new-in-class drug candidate of engineered Limosilactobacillus reuteri bacteria produces and releases the key human chemokine CXCL12 at the actual wound site. After delivery, ILP100 is designed to enhance the healing properties of immune cells in the wound. Phase I results released earlier this year indicate that ILP100-treated wounds in healthy subjects healed on average six days faster than controls. Bio-Me – Norway-based Bio-Me, a microbiome precision medicine company, secured NOK 10 million in financing that will be used to support development of clinical programs and explore additional business opportunities. These steps are part of the company’s strategic plan to position Bio-Me as a leader in microbiome-based Precision Medicine and contribute to optimal patient treatment and success of microbiome-based therapy. Bio-Me has developed a novel gut microbiome analysis tool dubbed Precision Microbiome Profiling, which offers a targeted approach to microbiome analysis/profiling using state-of-the-art qPCR technology. Cyxone – Following new data showing the potential of T20K, Sweden’s Cyxone AB entered into a research collaboration with Prof. Christian Gruber, the inventor of T20K & Prof. Gernot Schabbauer from the Medical University of Vienna. T20K is a potential first-in-class peptide drug candidate that shows promise as a novel and safe therapy which can halt the progression of multiple sclerosis. In animal models, T20K has been shown to both delay disease development and to halt its progression once disease has been initiated. The aim of the study is to deepen the understanding of the mode of action of T20K and to explore these new uses and the potential to provide significant additional therapeutic benefit in a model for multiple sclerosis. The study is expected to begin later this month, with planned readout in June 2022. Nonacus – Based in the United Kindgom, Nonacus and the University of Birmingham have partnered to develop a non-invasive test for bladder cancer. The test, which is expected to be available by mid-2022, will use highly sensitive liquid biopsy technology developed by Nonacus. Bladder cancer is the seventh most common cancer in the developed world. Nonacus intends to launch the new bladder cancer test within 12 months, and the final product will include access to bioinformatics software to help with analysis. The company expects the test will provide high sensitivity for all stages and grades of disease, and will ensure the test is available worldwide to laboratories, hospitals and clinics. Swissfillon AG – Swissfillon AG, a Swiss Drug Product Contract Manufacturing Organisation specializing in the sterile filling of highly potent liquid APIs, has supplied 0.8 million aseptically filled transport media in syringes for the Swiss Army Pharmacy’s COVID-19 PCR test kit. In less than 4 weeks, Swissfillon developed and established an efficient and reliable filling process for the transport medium, which the Swiss Army Pharmacy had procured from Zurich-based KlusLab. NVIDIA – U.K.-based NVIDIA launched Cambridge-1, the United Kingdom’s most powerful supercomputer, which will enable top scientists and healthcare experts to use the powerful combination of AI and simulation to accelerate the digital biology revolution and bolster the country’s world-leading life sciences industry. Its first projects with AstraZeneca, GSK, Guy’s and St Thomas’ NHS Foundation Trust, King’s College London and Oxford Nanopore Technologies include developing a deeper understanding of brain diseases like dementia, using AI to design new drugs and improving the accuracy of finding disease-causing variations in human genomes. Gyros Protein Technologies – Sweden’s GPT, part of Mesa Labs’ Biopharmaceutical Development Division, announced the next phase of its on-going collaboration with Cygnus Technologies, a Maravai LifeSciences company. The partnership introduced a new HEK 293 HCP immunoassay solution. The Cygnus HEK 293 HCP Assay Reagent Set for Gyrolab is the first of a planned range of ready-to-use bioprocess impurity reagent sets optimized for use with the Gyrolab platform to be developed by Cygnus as part of the expanded collaboration. Mallinckrodt plc – Ireland’s Mallinckrodt announced results from the pivotal Phase III STRATA2016 study assessing StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat), which is approved for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated. The trial, which evaluated the efficacy and safety of a single application of StrataGraft in adult patients with deep partial-thickness thermal burns, achieved both co-primary efficacy endpoints.

Netherlands-based Leyden Laboratories closed a €40 Million Series A financing led by GV (formerly Google Ventures) that will be used to develop the Leyden Labs’ platform and portfolio of product candidates. Leyden Labs uses its platform to target commonalities of viral families to protect against many viruses simultaneously as opposed to vaccines that typically protect against a specific virus variant. Its intranasal product candidates will be self-administrable, providing people with the freedom to protect themselves instantaneously from infection and prevent transmission. Funds will also be used to expand the company’s team. In addition to GV, the Series A was supported by F-Prime Capital, Casdin Capital, LLC and Brook Byers. David Schenkein, general partner at GV, and Stephen Knight, president and managing partner at F-Prime, will both join the board of directors of Leyden Laboratories. eTheRNA – Belgium-based eTheRNA immunotherapies NV was awarded a €6.9 million TIGER grant from the EU Commission that will be used to accelerate development of a novel, potentially best-in-class therapeutic mRNA cancer vaccine for treating recurrent/metastatic Human Papillomavirus strain 16 positive (HPV16+) cancers such as head and neck cancer, cervical cancer, anogenital cancer. Early data suggests mRNA may play a key role in treating cancers and autoimmune diseases with potential mRNA market of approximately $37 billion in 2030. RDIF – The Russian Direct Investment Fund partnered with India’s Virchow Biotech Private Limited to produce in the country up to 200 million doses per year of Sputnik V, the Russian-developed vaccine against coronavirus. In addition to the agreement with Vircow, RDIF also released a survey that showed its vaccine was one of the most recognizable in the world. According to the RDIF, the YouGov survey results showed 54% of the 9,417 respondents from nine countries considered Russia the most trusted vaccine producer alongside the United States. RDIF said its Sputnik V vaccine was also the most recognizable vaccine to the respondents. Of those surveyed, 74% said they knew the name of Russia’s vaccine. Sputnik V is also among top-two most preferred vaccines, just after the one produced by Pfizer and BioNTech, RDIF said in its release. Insightful Science – U.K.-based Insightful Science, a software company, will acquire Dotmatics, a cloud-based scientific R&D data management platform. By integrating Insightful Science’s software applications into Dotmatics cloud-first enterprise data management solution, the company will provide an end-to-end scientific research platform. This combination further improves laboratory efficiency and accelerates the pace of scientific innovation by facilitating more rapid data access, analysis and exchange between scientists around the world, the company said. Amolyt Pharma – Based in France, Amolyt announced positive data from the first cohorts of the single ascending dose portion of its Phase I clinical trial evaluating the company’s lead clinical candidate, AZP-3601, for the treatment of hypoparathyroidism. The data demonstrated a significant, sustained increase in blood calcium levels for at least 24 hours following a single administration of AZP-3601. Relief Therapeutics – Switzerland’s RELIEF and Acer Therapeutics entered into a collaboration for worldwide development and commercialization of ACER-001. ACER-001 is a proprietary powder formulation of sodium phenylbutyrate (NaPB) designed to be both taste-masked and immediate release. An ACER-001 pre-NDA meeting with the U.S. FDA is scheduled to occur in the second quarter of 2021. Acer expects to receive official meeting minutes approximately 30 days after the meeting. PhoreMost Ltd. -- PhoreMost Ltd., the UK-based biopharmaceutical company dedicated to “Drugging the Undruggable” disease targets, completed an oversubscribed £33 million (about $46 million) Series B investment round. The funding will be used to progress PhoreMost’s preclinical ‘Allosteric PLK1’ collaboration with Sentinel Oncology into the clinic in 2022. The programme is initially targeted towards Glioma. PhoreMost will also progress multiple additional internal first-in-class drug discovery programmes across both oncology and aging therapeutic indications. The funding round was led by BGF, the UK’s most active growth economy investor, and included new investors XtalPi Inc., Astellas Venture Management, Trend Investment Group, and o2h ventures. Existing investors Parkwalk Advisors, Morningside Ventures, and Jonathan Milner also contributed. Dunad Therapeutics – Also based in the U.K., startup Dunad Therapeutics emerged this week to develop next-generation small molecule therapeutics based on its highly differentiated, tuneable and targeted protein degradation technology. Dunad, secured initial financing from Epidarex Capital, a transatlantic venture firm that specializes in seeding and building exceptional early-stage life science companies. Dunad’s unique small molecule platform induces targeted degradation of disease-causing and often undruggable proteins via direct modification of the target using mono-valent small molecules. The company’s novel molecular approach is fully tuneable to be exquisitely selective and underpinned by a target-class agnostic mechanism of action that is distinct from other targeted protein degradation technologies. Dunad said its platform has the potential to unlock access to orally bioavailable and CNS-accessible degrader therapeutics and expand the frontiers of protein degradation targets. Step Pharma – Oncology and autoimmune disease focused Step Pharma, based in France, closed a €35 million Series B funding round. The proceeds will be used to advance Step Pharma’s lead proprietary CTPS1 inhibitor, STP938, into clinical development for the treatment of T-cell malignancies. In addition, Step Pharma will use the funding to advance development of CTPS1 inhibitors in other hematological malignancies and solid tumors. CTPS1 (cytidine triphosphate synthase 1) is an enzyme that plays a critical role in DNA synthesis, cell division and proliferation but whose function is highly selective to certain cell types, in particular proliferating T cells, making it an ideal target for drug development. The financing round was led by Sunstone Life Science Ventures and supported by existing investors Kurma Partners, Pontifax and Bpifrance, which reinvested through its Innovative Biotherapies and Rare Diseases fund and InnoBio 2 fund. Ilya Pharma – Sweden’s Ilya Pharma released new data from its clinical study of chronic wound treatment, ILP100. Ilya’s ILP100 gene therapy shortens healing time by on average six days, the company said. Additionally, scar volume also reduced by 30% through on-site production and delivery of key chemokine CXCL12 by transformed lactic acid bacteria. Ilya hopes to initiate a Phase II study later this year, if the ongoing COVID-19 pandemic allows. InteRNA Technologies – microRNA (miRNA)-focused InteRNA Technologies, based in the Netherlands, announced that preclinical data investigating the company’s lead candidate, INT-1B3, have been published in the peer-reviewed journals Molecular Therapy Nucleic Acids and Oncotarget. INT-1B3 is a mimic of the tumor suppressor miRNA-193a-3p and has the potential to address multiple hallmarks of cancer at the same time. The published results include data from tumor cell lines and experimental tumor models and support the high therapeutic potential of INT-1B3 in solid tumor indications.